FDA Inspection
Michael R. Migden, M.D.Michael R. Migden, M.D. – FDA Inspection, Oct 28, 2011
Record Details
This FDA Inspection record concerns Michael R. Migden, M.D., with an inspection on October 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Michael R. Migden, M.D.
- Inspection Date
- October 28, 2011
- Product Type
- Drugs
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ID · f298e3f3-e21b-445d-bf13-452eda788b5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752523
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety reports
- 21 CFR 812.100Investigator lack of informed consent
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Other FDA inspections of Michael R. Migden, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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